Shares of Boston Scientific (BSX) are up 49 cents, or 7%, at $7.63, in after-hours trading after the company announced at market close that it will resume sales of implantable cardioverter defibrillators (ICD), which were taken off the market in the U.S. a month ago when the Food & Drug Administration raised questions about the devices.
BSX said the FDA gave approval to reintroduce the devices with two manufacturing changes. The halt in ICD sales “may have a material impact” on the company’s results, which it plans to disclose during Q1 results.
BSX’s also said it expanded its own investigation into the matter and found that it had not submitted proper documentation of changes in manufacturing for some of its other ICDs, and that it is re-submitting paperwork to the FDA regarding those devices. It hopes to return those other ICDs — including Livian, Prizm, and other models — to the market in the U.S. “soon,” the company said.
“We are committed to doing the right thing every time,” said president and CEO Ray Elliott. “And we acted voluntarily, swiftly and appropriately to ensure compliance with all regulatory requirements. Our entire sales force is energized and hard at work!”
Analysts had written in recent weeks that the sales halt could cost Boston long-term market share as competitors such as St. Jude Medical (STJ) rushed into the vacuum.
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